BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ENDOLIGHT END IRRIGATING ENDO-ILLUMINATOR (20 GA. AND 19 GA.)

    K Number: K970882 · Decision Jun 24, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    39
    Applicant Total
    6
    Review Days
    106

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    Basic Information

    Device Name
    ENDOLIGHT END IRRIGATING ENDO-ILLUMINATOR (20 GA. AND 19 GA.)
    K Number
    K970882
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    American Medical Devices, Inc.
    Date Received
    March 10, 1997
    Decision Date
    June 24, 1997
    Product Code
    MPA
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MPA Endoilluminator

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    Other Clearances by American Medical Devices, Inc.

    K Number Device Name
    K974561 MOISTAIR FLUID AIR TUBING SET
    K971853 ENDOVIEW SPPHIRE LENS SET
    K970875 ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.)
    K970873 ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)
    K970878 ENDOLIGHT FIBEROPTIC REGULAR MONOFILAMENT AND FINE MONOFILAMENT